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Dual Haler - DH 0.8 - R - TP - ABS NV
EUDAMEDClass I (EU MDR)
Ref 03-118-29Model DPI inhalerModel DPI Inhaler
Identity
- Trade Name
- Dual Haler - DH 0.8 - R - TP - ABS NV EUDAMED
- Device Name
- Dual Haler - DH 0.8 - R - TP - ABS NV EUDAMEDDPI Inhaler EUDAMED
- Model / Reference
- DPI inhaler EUDAMED03-118-29 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898935580482 EUDAMED
- Basic UDI-DI
- B-07898935580482 EUDAMED789893558inhaler2N EUDAMED
- EMDN Code
- R03010302 AEROSOL PORTABLE INHALERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Germany EUDAMEDPortugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dual Haler - DH 0.8 - R - TP - ABS NV by Emphasys Importadora, Exportadora E Distribuidora Ltda. — Class I — MDR, MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07898935580482 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07898935580482 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000020354
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED 85425622-568e-40e7-b034-db726f4c710e 61 fields · synced Jul 15, 2026
- EUDAMED c8c1a26c-d48c-4113-bf52-3b4740e33c8b 61 fields · synced May 19, 2026